The da Vinci Surgical System is an advanced medical device used to perform surgery, which is produced by Intuitive Surgical Inc. In recent months, a number of complaints have been levied against users of the surgical system, and, perhaps more notably, Intuitive Surgical, for claims ranging from negligence to improper training and preparation. Given the increasing prevalence of da Vinci cases, The Expert Institute prepared a short primer on the da Vinci Surgical System, Intuitive, key facts for litigating da Vinci claims and what to look for in a da Vinci Robot expert witness.
Initially developed by the United States Department of Defense for use in military applications, robotic technology was adapted for medical use through the entrepreneurial efforts of two rival corporations, Intuitive Surgical, Inc. and Computer Motion, Inc. In the 1990s, these companies developed robotic interfaces for use in human surgical applications. Computer Motion introduced the Zeus Surgical System at approximately the same time that Intuitive Surgical developed its da Vinci Surgical System. Both technologies relied heavily on a laparoscopic patient-robot interface in which instruments were placed through small trocars implanted in the patient’s skin. The working field was maintained predominantly by insufflation of the peritoneal cavity with carbon dioxide. In 2000, Intuitive Surgical acquired Computer Motion consolidating robotic surgical technology and making Intuitive Surgical the sole provider of advanced robotic technology for use in human surgical procedures.
The da Vinci surgical system is unique in that it was the first operative surgical robotic system to be cleared by the FDA. Still, prior to its approval, there were predecessors to the da Vinci system that hinted at the potential in using robotics in surgery. For example, in 1997, the FDA approved the use of robotics for surgical assistance. Then, on July 11, 2000, the FDA approved the da Vinci system for use in gallbladder, gastroesophageal reflux, and gynecologic surgery. Subsequent decisions approved the device for use in:
- · thoracoscopic surgery
· laparoscopic radical prostatectomy
· thoracoscopically-assisted cardiotomy procedures
· mitral valve repair surgery
· totally endoscopic atrial septal defect
· gynecological laparoscopic procedures
The da Vinci Surgical System consists of a three or four-armed robot connected to a remote console. The operating physician is seated at the system’s master interface. The surgeon operates the system while seated at the console. Foot pedals are used for control, and 3-dimensional displays provide a unique and novel depiction of the surgical field not previously incorporated in other systems. Typically, 8- to 10-mm ports are used for the instruments, which have 7° of freedom, including rotation capabilities (mimicking the movements of the human wrist), and a special robotic EndoWrist.
Because of limited training provided to some physicians, combined with problems with the design of the da Vinci Surgical System, patients may face an increased risk of surgical complications.
In addition to mistakes caused by inexperienced surgeons, da Vinci surgery complications may arise from a design flaw in the device’s use of monopolar energy to cut, burn, and cauterize tissue. The da Vinci system also appears to have defective and inadequate insulation for the arms, which may allow the electrical current from the system to pass outside of the operative field, causing damage to surrounding organs, vessels, or tissue.
Further complicating the case, however, a da Vinci surgical injury may occur without the surgeon even being aware of it. As a result, many patients have been discharged following a da Vinci surgery, only to discover the injury days later. Patients then required readmission to the hospital, additional surgery, and, in some cases, experienced significant health issues. Because of the concerns, cases have alleged that the manufacturer of the device, Intuitive Surgical, failed to perform or sponsor sufficient testing to determine whether the da Vinci system is any safer or more effective than traditional surgical and laparoscopic methods. Critics also allege that Intuitive failed to adequately examine the long-term outcomes and minimized or withheld information about the true extent of complications and injuries following a da Vinci surgery.
A recent report in the Journal of the American Medical Association highlights some concerns in using robotic surgery systems and how these issues are affecting surgical subspecialties. The study highlighted the growth of the use of robotics in performing hysterectomies, and the complications associated with the procedure. Studying 264,768 women who underwent hysterectomies for benign gynecologic disorders at 441 hospitals from 2007-2010, the study concluded that while robotic-assisted hysterectomies were less likely to have a length of stay longer than two days, there were no substantial benefits in complication rates, transfusion requirements, and rate of discharge to nursing facilities. On average, however, the study noted that robotically assisted hysterectomies were $2,189 more expensive than hysterectomies performed using the traditional laparoscopic approach.
Litigating a da Vinci Claim
Surgeons who are enthusiastic about the technology say it allows them to operate with more precision. The robotic arms move in more directions than the human wrist, and the machine’s software helps to smooth out small hand tremors. Images on the video screen are also highly magnified, allowing the surgeon a better view of the patient’s anatomy. Still, proof that these advantages lead to better results has been elusive. In January 2012, the ECRI Institute, a national medical safety organization in Pennsylvania, published an article stating that robotic surgery was booming despite limited evidence that it worked better than standard operations.
While the benefits of the machine are inconclusive, the risks associated with its use are becoming clearer. Allegations range from improper training to negligence. At The Expert Institute, we find expert witnesses for attorneys. During the last year, we have seen a significant increase in the requests for a da Vinci Robot expert witness experienced with da Vinci Surgical Systems, specifically those familiar with its design, development, and implementation. In order to assist attorneys, we have compiled some of the most relevant information, including what to look for in a viable claim and experts needed to litigate these claims.
Harm indicative of viable cause of action in da Vinci Cases
When evaluating the possibility of a case involving the da Vinci Surgical System, there are a number of specific types of harm that are frequently litigated. This also applies when the suit is being brought against Intuitive for faulty design or manufacturing. Here are some of the more frequent instances of harm due to alleged breach that we have encountered.
The specific components of the device that come into contact with the patient are small, metal tools used to perform detailed procedures. In some cases, however, the items can become hot and cause minor to severe burns on organs and other tissue in the body. Similarly, small jolts of electricity may be emitted from the arms of the device, causing burns in the body. This can cause serious complications in the postoperative period, including:
Infections and Perforations
In some cases, the machine’s arms can have slight tremors or unintentional movements while in the body. This can cause perforations or punctures in surrounding tissues/ organs. Coupled with the risk of burns, this increases the chance of infection and subsequent complications.
Extended length of surgery/ switch to traditional laparoscopic surgery
While not necessarily indicative of an error, an extended surgery time or switch to traditional means of surgery, coupled with a later complication, is suggestive of an error during the procedure.
A foreign object in the body
An extension of res ipsa loquitur, the ends of the surgical arms have an assortment of moving parts, and in some cases, they can become dislodged and fall into the body. This can cause a number of health concerns for the patient.
The da Vinci Robot Expert Witness You’ll Need
A da Vinci Robot expert witness that is required when litigating these cases may include a myriad of specialties. The chart below shows the number of complaints filed with the FDA, organized by the type of surgery being conducted with the da Vinci System. In a case where inappropriate training is alleged, there are multiple steps that need to be analyzed to flesh out the details of the case.
The da Vinci Surgical System is a surgical device that can be used in a number of medical specialties. In most cases, a licensed physician familiar with the relevant procedure is needed to testify. While a number of different kinds of surgeons could be useful, we have narrowed down the top four, focusing on the different procedures that most frequently come up in complaints.
By far, the most frequent complaints regarding the da Vinci Surgery System involve procedures by an Ob/Gyn. One of the earliest FDA-approved uses for the machine was by Ob/Gyn’s, and due to its proliferation in the field, there have been numerous complaints. Hysterectomies had fifty-two complaints in 2012 and (thus far) in 2013. Furthermore, the ACOG (American Congress of Obstetricians and Gynecologists) released a statement saying that robotic surgery is not the only or the best minimally invasive approach for hysterectomy, nor is it the most cost effective option.
Except for hysterectomies, prostatectomies had the most complaints filed with the FDA during the measured time-period. Overall, urologists can operate on areas involving the urinary tracts in males and females, and the reproductive systems of males. Most frequently used on the prostate, as the technology evolves, urologists will begin using the machine on procedures involving the kidneys, adrenal glands, and bladder.
Thoracic surgeries utilizing the da Vinci Surgery System are growing, with surgeons becoming more comfortable with the device. The most frequent complaint with the da Vinci machine in these procedures involves mitral valve repair. Mitral valve repair is a cardiac surgery procedure performed to treat stenosis (narrowing) or regurgitation (leakage) of the mitral valve. The mitral valve is the inflow valve for the left side of the heart. Blood flows from the lungs, where it picks up oxygen, through the pulmonary veins, to the left atrium of the heart. After the left atrium fills with blood, the mitral valve allows blood to flow from the left atrium into the heart’s main pumping chamber called the left ventricle. It then closes to keep blood from leaking back into the left atrium or lungs. The techniques of mitral valve repair include inserting a cloth-covered ring around the valve to bring the leaflets into contact with each other (annuloplasty), with removal of redundant/loose segments of the leaflets (resection), and re-suspension of the leaflets with artificial (Gore-Tex) cords. Procedures on the mitral valve traditionally required a median sternotomy, but advances in non-invasive methods (such as keyhole surgery) allow surgery without a sternotomy. Minimally invasive mitral valve surgery is much more technically demanding and may involve higher risk. For an example of a case involving a thoracic surgeon, click here.
Another growing use of the da Vinci system is to remove small tumors inside a patient’s mouth. Generally, these procedures are performed by otolaryngologists, in which they remove tumors in the mouth and throat. In these procedures, complications can include burning, improper removal, and eventual infection.
While errors may be a result of inadequate training, a da Vinci Robot expert witness is needed to discuss the workings of the machine. The individual components, the inner-workings of the machine, and the functionality with the physician are all factors that should be established by a da Vinci Robot expert witness. Specifically, the machine is designed to make very specific and precise movements. A biomechanical engineer and biomedical engineer could be used to discuss the circumstances of the case, and any specifics of the machine that may relate to its operation. For example, if the case involves a burn due to the machine, which later became infected, a biomechanical engineer familiar with these type of machines may be needed to discuss the normal operating temperature, and potential reasons for an increased temperature. Monopolar energy instruments have been used in both open and laparoscopic surgeries for decades, but it was rare for these complications to go unnoticed. Some surgeons maintain that the tactile sense is not preserved when conducting surgery from behind a computer console.
Medical device warning
If an attorney alleges failure to familiarize physicians with the system before allowing them to conduct surgery, a medical device warning expert would be needed in order to discuss the adequacy of the warnings and instructions provided to the physicians. Similar to experts in pharmaceutical labeling, experts in medical device warnings can speak to industry practices, the manner in which warnings are written, and possible defects in the warnings associated with the da Vinci Surgical System.
In most circumstances, hospital administrators are the final voice when determining what procedural steps need to be taken when utilizing a new technology. According to the New York Times, one of the major complaints levied against Intuitive was that their salespeople presented themselves as experts, and encouraged administrators to reduce the amount of training time using the device. Plaintiffs allege that this was done in order to drive sales, and that Intuitive disregarded the safety concerns associated with reduced training time. Given these concerns, hospital administrators should be called to discuss the standard of care in setting hospital policies. Specifically, administrators could describe the industry-practice of accepting a salesperson’s suggestion, normal procedures for new medical device safety, and how procedures are created.